Therapeutic undergarments for the treatment of functional gastrointestinal disorders including irritable bowel syndrome

ABSTRACT

An apparatus, system, and method for analysing and/or treating symptoms of IBS. A system for treating IBS may include a processor configured to receive a first set of data from biosensors configured to measure contractions in the bowel, receive a second set of data from a galvanic skin response sensor configured to measure electrical conductance of the skin, and analyze patterns between the first and second sets of data. An apparatus may include a base material comprising a material that fits to the body of a user, an elastic portion capable of applying compression across the abdomen of a user, and a tension adjusting mechanism for adjusting the compression applied to the abdomen in order to treat the symptoms of IBS.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. application Ser. No.14/866,762, entitled “THERAPEUTIC UNDERGARMENTS FOR THE TREATMENT OFFUNCTIONAL GASTROINTESTINAL DISORDERS INCLUDING IRRITABLE BOWELSYNDROME” and filed on Sep. 25, 2015, which claims the benefit of U.S.application Ser. No. 62/056,367, entitled “THERAPEUTIC UNDERGARMENTS FORTHE TREATMENT OF FUNCTIONAL GASTROINTESTINAL DISORDERS INCLUDINGIRRITABLE BOWEL SYNDROME” and filed on Sep. 26, 2014, the entirecontents of both of which are expressly incorporated by reference hereinin their entirety.

BACKGROUND Field

Aspects of the present disclosure relate to a method and apparatus fortreating functional gastrointestinal disorders including irritable bowelsyndrome.

Description of the Related Art

Functional gastrointestinal disorders (FGIDs) are disorders that arecharacterized by persistent and recurring gastrointestinal (GI)symptoms. These occur as a result of abnormal functioning of the GItract. They are not caused by structural (tumors or masses) orbiochemical abnormalities. The most prevalent FGID is Irritable BowelSyndrome (IBS)—abdominal pain associated with altered bowel habits ofdiarrhea, constipation or both. Bloating and abdominal distention arealso frequently reported by patients with IBS.

IBS affects up to 15% of the US adult population. 50-80% of people withIBS symptoms do not consult a physician, although they may takeover-the-counter medications and report significantly more jobabsenteeism and disability than people without these symptoms. It hasbeen reported that IBS is the second leading cause, after the commoncold, for missing work or school.

SUMMARY

Aspects presented herein include a method and apparatus for treatingFunctional

Gastrointestinal Disorders, including Irritable Bowel Syndrome. Aspectscan be deployed, activated, engaged, and/or adjusted in real-time tohelp patients manage acute symptoms of IBS and provide patients withcontrol, both real and perceived, over the symptoms of IBS and itsimpact on their lives.

Aspects of the disclosure include an apparatus for treating symptoms ofIBS. The apparatus includes a base material comprising a material thatfits to the body of a user, an elastic portion capable of applyingcompression across the abdomen of a user, and a tension adjustingmechanism for adjusting the compression applied to the abdomen in orderto treat the symptoms of IBS.

Aspects also include a system for treating IBS, the system having aprocessor configured to receive a first set of data from biosensorsconfigured to measure contractions in the bowel, receive a second set ofdata from a galvanic skin response sensor configured to measureelectrical conductance of the skin; and, analyze patterns between thefirst and second sets of data.

Aspects further include a method of treating IBS symptoms comprisingapplying a base material garment comprising a material that fits to thebody of a user, tensioning an elastic portion capable of applyingcompression across the abdomen of a user, and adjusting the compressionapplied to the abdomen in order to treat the symptoms of IBS.

Additional advantages and novel features of aspects of the presentinvention will be set forth in part in the description that follows, andin part will become more apparent to those skilled in the art uponexamination of the following or upon learning by practice thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of the function of the Brain-Gut Axis.

FIG. 2 is a schematic view of how IBS can become a chronic,self-perpetuating syndrome.

FIG. 3 is a conceptual example of the manner by which IBS can become achronic, self-perpetuating syndrome.

FIG. 4 is a table listing common IBS treatments by type.

FIG. 5 is a schematic view of the colon, set inside the outline of amale human body on the left, and magnified on the right with variousparts of the colon identified.

FIG. 6 is a semi-perspective view of one example apparatus, inaccordance with aspects of the present invention; the parts of the colonthat are compressed by this example being highlighted.

FIG. 7 is a schematic view of the manner by which gas pressure distendsthe colon outward and activates stretch receptors.

FIG. 8 is a schematic view of how aspects of the invention exertexternal compression and counteracts colonic expansion.

FIGS. 9A-9C provide perspective views from the front, back, and side ofa female patient wearing an example apparatus in accordance with aspectsof the present invention, worn about the torso, from just below the bustline down to the pubic line.

FIGS. 10A and 10B provide perspective views from the front and angledback of a female patient wearing an example apparatus in accordance withaspects of the present invention comprising a thong bottom with anundergarment extension that covers the torso up to the rib line.

FIGS. 11A and 11B are a frontal and back perspective view of a femalepatient wearing an example apparatus in accordance with aspects of thepresent invention comprising an undergarment camisole that extends fromthe shoulders to the pubic line.

FIG. 12 is a frontal perspective view of a female patient wearing anexample apparatus in accordance with aspects of the present inventioncomprising an undergarment tube top shirt that covers the breasts andtorso and extends down to the pubic line.

FIG. 13 is a frontal perspective view of a female patient wearing anexample apparatus in accordance with aspects of the present inventioncomprising a body undergarment that covers the thighs, torso, andbreasts, and has shoulder straps.

FIGS. 14A and 14B provide perspective views from the front and back of afemale patient wearing an example apparatus in accordance with aspectsof the present invention comprising underwear with a high rise torsocover that extends to the diaphragm.

FIGS. 15A and 15B provide perspective views from the front and back of afemale patient wearing an example apparatus in accordance with aspectsof the present invention comprising hip and lower abdomen undergarmentthat extends from the mid-thighs up to just past the navel and umbilicalline.

FIG. 16 provides perspective views from the front and back of a malepatient wearing an example apparatus in accordance with aspects of thepresent invention comprising a sleeveless undergarment t-shirt thatextends from the shoulders down across the torso to the pubic line.

FIGS. 17A and 17B provide perspective views from the front and back of amale patient wearing an example apparatus in accordance with aspects ofthe present invention comprising underwear with a high rise cover thatextends up just past the umbilical line.

FIG. 18 presents an example system diagram of various hardwarecomponents and other features, for use in accordance with aspects of thepresent invention.

FIG. 19 is a block diagram of various example computer systemcomponents, in accordance with aspects of the present invention.

FIGS. 20A and 20B are diagrams that depict anatomical references used todescribe areas and planes across the front and side of the human torso.

FIG. 21 is a frontal perspective of the lower abdomen of a patientwearing an example apparatus in accordance with aspects of the presentinvention comprising an abdominal band.

FIG. 22 is a frontal perspective of the lower abdomen of a patient withthe left midclavicular line indicated, wearing an example apparatus inaccordance with aspects of the present invention comprising an underwearbottom with an undergarment extension that covers the torso up to therib line.

FIGS. 23A and 23B provide perspective views from the front and back of afemale patient, wearing an example apparatus in accordance with aspectsof the present invention comprising an abdominal band.

FIG. 24 provides a perspective view from the front of a female patientwith the suprapubic line indicated, wearing an example apparatus inaccordance with aspects of the present invention comprising underwearthat extends up to just below the umbilical line.

FIG. 25 provides a perspective view from the front of a female patientwith the left midclavicular line indicated, wearing an example apparatusin accordance with aspects of the present invention comprising anunderwear bottom with an undergarment extension that covers the torso upto the rib line.

FIG. 26 provides a perspective view from the front of a female patientwearing an example apparatus in accordance with aspects of the presentinvention comprising an abdominal band.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of various configurations and isnot intended to represent the only configurations in which the conceptsdescribed herein may be practiced. The detailed description includesspecific details for the purpose of providing a thorough understandingof various concepts. However, it will be apparent to those skilled inthe art that these concepts may be practiced without these specificdetails. In some instances, well known structures and components areshown in block diagram form in order to avoid obscuring such concepts.

While the etiology of IBS remains unclear, at least three primarymechanisms may produce symptoms of IBS: Dysmotility, VisceralHypersensitivity, and Brain-Gut Dysfunction.

Motility involves the muscular activity of the GI tract, which isessentially a hollow, muscular tube. Normal motility includes an orderlysequence of muscular contractions from top to bottom. In IBS, motilityis abnormal. There can be muscular spasms that cause pain and thecontractions can be very rapid, or very slow or disorganized, leading todiarrhea and constipation, respectively. This is known as dysmotility.

Sensation involves how the nerves of the GI tract respond to stimuli(e.g., food, digesting a meal, intestinal gas). In IBS, the nerves aresometimes so sensitive that even normal contractions can bring on painor discomfort. This is known as visceral hypersensitivity.

Brain-gut dysfunction involves the disharmony in the way that the brainand GI system communicate. With IBS, the regulatory conduit betweenbrain and gut function may be impaired in a way where IBS symptoms begetanxiety which beget additional symptoms, and so on.

The communication between the brain and the gut via the nervous systemis known as the brain-gut axis. The relationship is bi-directional innature, as depicted in FIG. 1. This means that activities in the gut canaffect mood, perception, and behavior, and reciprocally that emotionscan affect gut activity. An example of the brain-gut axis is thestatement, “I have butterflies in my stomach,” from a personanticipating a dramatic or stressful event.

Given the involvement of the brain in IBS, researchers have attempted tocharacterize the disorder with explanatory models that incorporatecomponents derived from psychological theories. Particularly relevant toIBS is the cognitive behavioral approach. Similar to the brain-gut axisconcept, cognitive behavioral theory stipulates that the relationshipbetween thoughts, feelings, and behaviors (or physiological outcomes) isbi-directional: certain thoughts provoke certain emotions that have atendency to precipitate certain behaviors, and vice versa. The nature ofthis relationship serves as the basis for the cognitive behavioral modelfor IBS as well as for cognitive behavioral therapy (CBT).

The goal of cognitive behavioral therapy is to help patients changeundesirable emotions, behaviors, or physiological responses by examiningthe patient's underlying thoughts, mental processes, and interpretationsof events. Cognitive psychology holds that the brain makes numerousassumptions (also known as heuristics) that help filter stimuli andallow decisions to be made quickly and efficiently. Individuals aregenerally unaware of these assumptions and this is typically an asset.However, when a maladaptive or irrational assumption becomes the basisfor mental assessment or interpretation, undesired feelings andbehaviors are often the result. Yet despite negative consequences,individuals struggle to identify the disordered thinking that leads tothe undesired outcomes.

Behavioral psychology focuses on the underlying processes, emotions, andmotivations that influence behavior. The behavioral psychologycontribution most relevant to CBT is the concept of reinforcement.Reinforcement is anything that can make a person more or less likely torepeat a certain behavior. Punishment is also a type of reinforcementbut is not discussed as it is less relevant. Reinforcement can bepositive or negative, as well as internal or external. The table belowprovides an example of common types of reinforcement:

Internal (Intrinsic) External (Extrinsic) Positive Artist completes aChild gets straight A's in (Something is masterpiece work; school;Parents give added) Provokes feelings of child $10 for each A;satisfaction, boosts Child gets straight A's self-esteem; Artists again.will continuing painting with passion Negative Person with OCD has POWwon't reveal key (Something is (irrational) fear of information; Painfultaken away) contamination, relieves electric charge is applied anxietyby washing to body by captors; hands and avoiding POW reveals keyshaking with others; information to avoid behaviors will bereapplication of painful constant, ritualistic charge over time

Cognitive behavioral therapy incorporates the concept of reinforcementto help explain the chronic nature of many psychological disorders orphysiological disorders with a psychological component. Astraightforward example of the role of reinforcement is addiction.Consider a man that is experiencing heightened anxiety due to recent jobloss. Despite an upcoming interview with a new firm, he feels that he's“never measured up and can't understand why the firm would want him.”

This mental state is unpleasant. One evening after several glasses ofwine he realizes he feels more relaxed and less anxious. As a result,the next evening when he feels anxious, he repeats the behavior(drinking alcohol) in order to achieve the desired effect. He thenbegins drinking during the day to relieve his anxiety over unemployment.When he finally has his job interview, he is very anxious and he drinksprior to the interview to relieve this anxiety. The employer noticesthat he is intoxicated and does not offer him the job. Losing the jobopportunity provokes greater anxiety for the man, which leads him todrink more frequently, creating additional negative consequences. Thisexample demonstrates how an irrational assumption (“They'd never hireme”) can lead to a mental state (anxiety) that is resolved by anundesirable behavior, the impact of which leads an outcome thatvalidates the original, maladaptive assumption (e.g. he isn't hired forthe job, provoking greater anxiety and more drinking). This is known asa positive or self-perpetuating feedback loop: disordered thoughts,emotions, and behaviors reinforce themselves in a continual process.

The concept of the self-perpetuating feedback loop is very applicable toIBS, and is illustrated in FIG. 2. The cognitive behavior model of IBSproposes that symptoms (e.g. abdominal pain, dysmotility, bloating)originate due to a combination of factors including geneticpredisposition, infection, inflammation, hormonal changes, altered gutmicrobiota, illness, and stressful life events. As the symptoms of IBSare unpleasant and disruptive, patients become fearful and anxious thatthe symptoms will reoccur. This anxious state leads to dysmotility viathe brain-gut axis while promoting increased attention to and perceptionof visceral sensation, resulting in hypersensitivity. Dysmotility andhypersensitivity lead to additional IBS symptoms and life disruption,which generates additional anxiety, and thus the cycle perpetuates.

A conceptual example of how IBS is perpetuated, resulting in impairedquality of life, is provided in FIG. 3. As illustrated in FIG. 3, anindividual is anxious about experiencing IBS symptoms during a jobinterview. The job applicant's anxiety provokes IBS symptoms, causingher to become flustered during the interview. The IBS symptoms alsocause her to visit the rest room twice. The interview goes poorly, whichfurther reinforces her anxiety regarding her IBS symptoms. Thisreinforcement heightens her anxiety at the next interview which willresult in the same IBS symptoms.

Despite the significant social and economic impact of IBS and thevariety of available treatments, there is no ‘silver-bullet’ to treatthe disorder. A list of current treatments is displayed in FIG. 4. Thesetreatments are similar in that they are all only marginally effective.In addition, certain treatments such as prescription medications arevery expensive.

That currently available treatments for IBS are consistently effective,yet only marginally so, is due to the fact that they are primarilytreating the physiological symptoms of the disorder, while leaving thepsychological component relatively unaddressed. To better understand whyexisting treatments are only marginally effective, it is helpful tointroduce a third psychological concept: Locus of control.

Locus of control refers to the extent to which individuals believe theycan control events that affect them. This belief is significantlyinfluenced by an individual's previous experiences and they way he orshe interpreted them. Individuals with a strong, internal locus ofcontrol believe that they can affect outcomes with their behavior, whilethose with a weak, external locus generally attribute outcomes tofactors over which they have no control or influence. Beliefs associatedwith a weak locus of control (e.g. “It doesn't matter what I do, theoutcome won't change” and “Why should I even try?”) are associated withanxiety, depression, and other psychological disorders; conversely, evensmall instances of control (e.g. a child deciding how to organize his orher bedroom) tend to promote improved self-esteem and mental wellbeing.

Patients generally have a very weak locus of control with respect to IBSdue to the unpredictability of the symptoms and their inability toprevent or inhibit them. In fact, often IBS patients feel that thesymptoms occur “always at the worst possible time, as if someone isplaying a mean joke on me”, in their eyes maximizing the negative impacton their life. What many patients fail to realize is that they are alsomore anxious during periods which an IBS attack would be “devastating”,simply due to the enhanced importance of the situation, such as a jobinterview.

Returning to the currently available treatments for IBS, each acts in anindirect, non-acute manner to reduce symptoms, despite the fact that thepatient with IBS experiences the symptoms in a very acute, direct way.As a result, none of the current treatments effectively improve thepatient's sense of control over the symptoms. The need for IBStreatments that take into account patients' sense of control isexemplified by the fact that in IBS drug studies dosing frequency (whencumulative dosing amount is held constant) shows a strong positivecorrelation with efficacy in both drug and placebo study groups. Themore frequent the dosing, the greater the efficacy, implying that thepatients who received the most benefit are those given the ability totake specific action (e.g. take a dose) that they perceive will reducecurrent IBS symptoms or reduce the likelihood of an acute occurrence ofIBS symptoms.

Neglecting the patient need for acute control and symptom managementinhibits currents treatments from being maximally effective. Althoughsome efficacy in symptom reduction is achieved, the treatment behavior(e.g. taking a pill in the morning, avoiding dairy products) is too farremoved from the patient's acute experience of symptoms (or lackthereof) to create and reinforce a strong positive association in thepatient's mind between their action and symptom relief ornon-occurrence. (Consider the results had Pavlov rung his bell 6 hoursbefore feeding his dogs versus immediately prior to the meal.) As aresult, despite some efficacy in reducing symptoms, current treatmentsfail to effectively interrupt the IBS feedback loop thus and remain onlymarginally effective.

Accordingly, there is a great need for IBS treatment modalities that notonly target and reduce symptoms, but also provide patients with a senseof control over the syndrome and its impact on their lives. The lattercan be most effectively achieved with treatments that can be acutelydeployed and augmented by the patient in response to symptoms or to the(patient's) expectation of symptoms in the near-term

Aspects presented herein include a method and apparatus for treatingFunctional Gastrointestinal Disorders, including Irritable BowelSyndrome. Aspects can be deployed, activated, engaged, and/or adjustedin real-time to help patients manage acute symptoms of IBS and providepatients with control, both real and perceived, over the symptoms of IBSand its impact on their lives.

An abdominal wrap, as presented herein, generates broad, uniform lowerabdominal pressure and delivers additional, focused pressure to thesigmoid and descending colon, which helps to reduce IBS symptoms.Research yielded the identification of several mechanisms of action thatwe hypothesize are responsible for this unexpected, previously unknownefficacy. These mechanisms are described in the table below.

Application Target Symptom/Mechanism of Intervention Site ActionCompression Sigmoid Dysmotility; compression reduces and Colon; preventsspasms in sigmoid/descending Sigmoid/ colon and relax the muscles. Thisreturns Descending contractions to normal. Colon Compression Sigmoid/Hypersensitivity/pain; Gate control theory: Descending transcutaneouspressure applied to colon; anatomical site(s) from which pain signalsLower originate blocks pain signals from reaching abdomen brain.generally Compression Sigmoid/ Distention/Bloating: Externally appliedDescending compression prevents excessive expansion colon of colon lumendue to accumulation of gas. Artificial Lower Distention/Bloating:Artificial abdominal abdominal abdomen wall resistance counteractsabnormal, wall generally paradoxical abdominal wall musculatureresistance Sigmoid/ response to intestinal gas and pressure thatDescending occurs in patients with IBS. colon; Acutely Sigmoid/Brain-Gut Axis Dysfunction: Provides deployed, Descending patients withcontrol (real and perceived) patient- colon; over symptoms and symptommanagement. modulated Lower Inhibits IBS feedback loop far moretreatment abdomen effectively than current treatments. generally

Additional mechanisms that may also be useful in treating IBS includethe following.

Hot Sigmoid/ Dysmotility: heat to help relieve spasms CompressionDescending and relax muscle. colon Hot/Cold Sigmoid/Hypersensitivity/pain: Hot and cold Compression Descending compress toblock pain signals when colon; applied to site of signal generation. ForLower example, a study at the University College abdomen of London usedDNA technology to generally monitor heat and pain receptors withincells. Temperatures over 104 F. switched on internal heat receptors(TRPV1) which block the effect of chemical messengers that cause pain onthe pain receptor (P2X3). Transcutaneous Sigmoid Hypersensitivity/pain;Gate control theory, Electrical Colon; electrical signals generated byTENS Nerve Sigmoid/ applicator inhibit pain signal generationStimulation Descending when applied to site of pain. Also possible(TENS) Colon; to inhibit pain signals through application Lumbar of TENSto site at which nerves innervating pain site connect to spinal chord.Reciprocal Lumbar, Distention/Bloating: Reciprocal inhibition InhibitionAbdominal is tendency for muscles on one side of Wall joint/axis torelax in response to contraction of muscles on other side. Mechanismsthat relax muscles in lower back/lumbar region can promote contractionof abdominal wall to counteract abnormal relaxation in patients withIBS. Biofeedback Abdominal Distention/Bloating: Wearable mechanism Wallthat detects and measures contraction and relaxation of abdominal walland provides feedback to the wearer when unconscious relaxation of theabdominal wall is occurring, so that the user can recognize this andconsciously contract the abdominal wall in response. BiofeedbackSigmoid/ Brain-Gut Axis Dysfunction; Biosensors Descending capture andstore physiological data (e.g. colon; heart rate, muscle contractions,Lower perspiration, bowel movements, etc..). abdomen; Whenstored/captured alongside Skin concurrent thoughts/feelings/behaviors,generally can provide basis for pattern recognition and therapy.

The various aspects disclosed herein incorporate one or more of thesetreatment mechanisms into forms and designs that are easily integratedinto patients' lives.

One example, in according with aspects of the present invention,depicted in FIG. 6, includes an elastic or semi-elastic band 40 that iswrapped externally around the patient's lower abdomen, with one side ofthe band being fastened securely to the other side of the band with aclosing mechanism 42. On the exterior of the band 40, there may be anelastic or semi-elastic secondary band 44 that may be attached so thatwhen its sewn edge 46 is properly positioned behind the patient's lefthip, the secondary band 44 may be stretched horizontally across the leftlower abdomen (sigmoid and descending colon area) and secured to theexterior of the primary band 40 with a closing mechanism 48. Thisexample includes aspects that apply compression to the colon asindicated by the highlighted regions of the colon depicted in FIG. 6.The treatment effect of this embodiment (compression) may be adjusted bythe patient using the closing mechanism 48 on the secondary band 44.

General lower abdominal pressure is generated along with additional,targeted pressure to the sigmoid and descending colon. The sigmoid anddescending colon regions (collectively known as the left colon) aregenerally the most problematic anatomical sites for IBS patients. Thesigmoid colon is the part of the large intestine known to have the mostdense, and thus the strongest, muscular fibers. Stool is desiccated andpackaged into a solid form by the time it reaches this area. As aresult, stronger muscular contractions are required to push the stooldown into the rectum and then to evacuate it. This area is not only themost muscular portion of the colon but is often the most redundant,demonstrating loops of elongated bowel that trap gas and portions ofstool.

Aspects presented herein reduce symptoms for IBS patient by targetingtwo different mechanisms, each addressing a hallmark feature of thesyndrome (dysmotility and visceral hypersensitivity, respectively).Dysmotility is typically associated with painful cramps and diarrhea,constipation, or both, due to spasms in the patient's left colon. Theinvention targets this area with focused compression. When the device isapplied, the frequency and intensity of the spasms are reduced, and thecolon relaxes into a more normal contraction pattern.

The other IBS hallmark feature the invention addresses is visceralhypersensitivity.

This is the tendency for patients with IBS to ‘over feel’ digestiveactivities in their bowels relative to non-IBS patient counterparts. Instudies, IBS patients report pain (due to gas, bloating, distention,spasms, pressure, etc.) when healthy patients exposed to the samestimuli (e.g. same volume of gas in sigmoid colon) do not.Hypersensitivity is caused by dysfunction in the way the brain and gutcommunicate via the nervous system. Although the specific mechanism ofdysfunction remains unclear, certain nerve pathways that connect the gutto areas in the brain associated with pain may become overactive inpatients with IBS, while likewise, pathways that dampen pain sensitivitymay become inhibited.

The invention reduces visceral hypersensitivity by providing a stimulithat ‘closes the gate’ and blocks pain signals from reaching the brain.The phrase ‘closing the gate’ refers to the Gate Control Theory of Pain,first proposed in 1965 by Ronald Melzack and Patrick Wall. Gate ControlTheory states that the activation of nerves which do not transmit paincan interfere with signals from pain fibers, thereby inhibiting pain. Asa result of the compressive force generated across the sigmoid anddescending colon particularly, and the lower abdomen generally, theinvention stimulates non-pain nerve pathways that help block theoveractive pain pathways present in IBS patients.

The invention also provides relief from bloating and distention, bothvery common symptoms of IBS. The device helps in three ways: 1) bylimiting the circumference of the colon, particularly in the descendingand sigmoid areas; 2) by providing artificial abdominal wall resistance,and; 3) by provoking contraction of the abdominal muscles and diaphragm.

The circumference of the colon can grown in response to gas pressure.Gas pressure inside the colon exerts outward force on the colon wall,thereby increasing the circumference of the colonic lumen. (See FIG. 7).The increase in circumference triggers afferent signal pathways onstretch receptors within the circular muscle layer of the colon wall.The afferent receptors then send a signal of pain to the brain (See FIG.7). When the compression is applied, the compression translates externalforce into the abdominal cavity and onto the walls of the colon. Thisexternal pressure helps counter the internal pressure generated bycolonic gas, preventing a large increase in the circumference andstretch of the colon wall (See FIG. 8).

Aspects presented herein also provide artificial abdominal wallresistance. This is important due to the fact that the abdominal musclesand diaphragm of patients with IBS tend to have an abnormalpost-prandial response to a meal and well as general intestinal gas andpressure. In healthy patients, the abdominal wall and diaphragmgenerally contracts and tightens following a meal or in response tointestinal gas and pressure. The exact opposite is true, however, inpatients with bloating and distention. In response to food intake, gas,and pressure, the abdominal wall and diaphragm of patients thatexperience bloating and distention tend to paradoxically relax ratherthan contract, allowing the stomach and abdomen to shift downward andoutward. By providing both general abdominal compression, as well asfocused compression to the sigmoid area, the invention compensates forIBS patients' inappropriate relaxation of the abdominal wall. This meansthat bloating, gas, and distention are reduced. Other aspects of theinvention may reduce bloating and distention by provoking contraction ofthe abdominal muscles and diaphragm, or by reminding the patient toactively contract these muscles, in order to counteract abnormalrelaxation. Aspects that may be incorporated to provoke musclecontraction include transducers that apply transcutaneouselectro-stimulation to the affected region (direct stimulation) as wellas aspects that provoke contraction using one or more of the humanbodies known reflex responses (indirect stimulation) such as reciprocalinhibition and the superficial abdominal reflex. The superficialabdominal reflex refers to the tendency for the abdominal wall tocontract in response to gentle stimuli (such as a light stroking by afinger) applied upon the skin surface of the abdomen.

Another mechanism that contributes to the invention's effectiveness intreating IBS is the fact it can be deployed or engaged rapidly by thepatient to address acute symptoms, and that its primary treatmentmechanisms are easily adjustable by the patient. As previouslydiscussed, providing IBS patients with a greater sense of control overtheir treatment and symptoms aligns well with the suspectedpsycho-pathophysiology of the disorder. That is, by allowing them tofeel in control of managing ‘treatment level’ and symptom reduction, theprobability of the patient having successful experiences that he or sheattributes to his or her own action will increase. This will createmeaningful reductions in the patient's anxiety over time as his or hersense of control and confidence is repeatedly reinforced.

Aspects presented herein may include incorporating treatment mechanismsinto undergarments that patients can wear under their normal clothesduring the day. The undergarments may be sewn in various shapes andsizes and for male and female physiques. In general, the apparatus maybe sewn with fabrics and in such a way that it adheres relativelyclosely or tightly to the body of the wearer. This can be importantbecause it allows the garment to be relatively tight fitting, and adhereto the body of the wearer, to enable the therapeutic features of thegarment to be optimally deployed. The garment may be predominantlycomposed of one or more fabrics such as nylon, neoprene, cotton,spandex, polyester, synthetic fiber fabric, or any other fabric ormaterial known for use in athletic, high-performance, and specialtypurpose clothing. The garment may comprise, e.g., a fabric, composite,or material that is capable of being worn under clothing. The garmentmay cover at least the sigmoid colon region of the torso. The garmentmay incorporate one or more features that affect the sigmoid anddescending colon and/or the general abdominal and lumbar region for thepurpose of reducing symptoms of FGIDs including irritable bowelsyndrome. The mechanism of action of these features may includeproviding support and compression, heat or cold therapy, and stimuli,including electrical, magnetic, sonic, or any other type of stimuli knowfor use to inhibit or excite certain sensory pathways; also, monitoringand transmitting bio-signals, providing artificial abdominal wallresistance, responding automatically to bio-signals, providingbiofeedback to the patient, providing mechanisms that allow the patientto adjust of treatment effect, providing pressure or trigger pointtherapy, providing pressure or trigger point therapy to inducerelaxation or contraction of abdominal, pelvic, and lower back (lumbar)musculature.

The garments may designed to be worn as undergarments for symptom reliefduring the day. Unless otherwise noted, the base or primary material forthe example undergarments will be denoted with 50 in each illustration.The base material 50 for each undergarment may be predominantly composedof one or more fabrics such as nylon, neoprene, cotton, spandex,polyester, synthetic fiber fabric, or any other fabric or material knownfor use in athletic, high-performance, and specialty purpose clothing.In this regard, the base material of the garment, or at least asignificant portion of the garment, may be composed of a fabric orcomposite that has elastic or semi-elastic properties similar togarments generally known as ‘Shapewear’, or if relatively inelastic, becomposed of a material that closely fits the intended wearer. Thegarment may be composed predominantly of a fabric, composite, ormaterial that is capable of being worn comfortably under primaryclothing.

One example comprises a shape-fitting undergarment for female patientsthat covers the torso from the pubic line to just below the bust line.This example is illustrated in FIGS. 9A, 9B, and 9C. Sewn horizontallyacross the lower front portion of the undergarment 51 are several stripsof hook-compatible loop material 52. Additional elastic or semi-elasticstrips 54 may be sewn to the undergarment so that they extendhorizontally from just behind the patients left hip around the left hipand across the left lower abdomen from left to right. The strips 54 canthen be stretched from left to right across the lower abdomen andfastened to the loop strips 52 using a hook closing mechanism 56attached to the elastic strips 54. In this example, it may be importantthat some vertical space, even if minimal, be left between thehorizontally sewn loop strips 52 and elastic strips 54. Providing spacewill allow the apparatus to generate compression, but will prevent thetendency for the elastic straps to roll when the patient bends at thewaist. Also, there may be a reinforcement 58 sewn into the back side ofthe garment, near where the elastic strips 56 are sewn to the primarymaterial 50. This reinforcement 58 may help prevent the elastic strips56 from pulling the base material 50 out of place when the strips 56 arestretched and fastened.

In an alternative example 60 for female patients, illustrated in FIGS.10A and 10B, base material 50 comprises thong underwear that extends upacross the torso to just below the bust line. There is an elastic orsemi-elastic strap 61 that is sewn at an angle on its bottom end acrossthe left lower abdomen, below the umbilicus. The strap 61 the extendsout over the left hip and wraps around the patient's back from left toright, finally re-emerging on the patient's front right side, just belowthe diaphragm. In being wound around the patient's body, the strap 61 ispassed through several simple loops 64 sewn to the base material 50 thathelp keep the strap 61 in place. The strap 61 is fastened to the topportion of the undergarment using a closing mechanism 66. This examplemay be desirable because compression of the sigmoid and descending colonis achieved without having straps or compression materials wrappedacross the lower abdomen which is undesirable for certain patients.Additional aspects may include a second strap that begins on the rightside of the abdomen, opposite from the strap 60, and circumvents thepatients body in the opposite direction.

FIGS. 11A and 11B depict another example for female patients, comprisingan undergarment camisole 70 with a butterfly compression mechanism 72and an insert pouch 74. The camisole 70 extends from the patientsshoulders across the torso and abdomen down to the pubic line. Thecamisole comprises a base material 50. Situated over the patient's lowerabdomen, over top of the base material 50, is a butterfly compressionmechanism 72 that features four straps 76 that originate from an ovalshaped pouch 74, situated over the sigmoid colon to the left of thevertical midline of the abdomen. The pouch 74 is capable of holdingvarious types of inserts including hot and cold packs,electro-stimulators, and biosensors. Each of the four straps 76 may beconnected to a mechanism for adjusting the tension on the straps. Forexample, on the back side of the garment the straps may connect to athin wire loop 78 that feed into a small circular crank situated in themiddle of the patients back 79. This crank 79 allows the patient toeasily adjust how intensely the pouch is compressed into the sigmoidcolon. The pouch may be excluded, and the number of straps may bevaried. For example, the apparatus may include only 2 straps instead offour. Instead, the two straps may be sewn along a vertical edge of thestrap to the base material 50, directly above the sigmoid colon. Hookfabric may be sewn onto the end of each strap not sewn to the basematerial. The straps may then be stretched and wrapped around thepatient's left and right hips, respectively, and attach to hook materialon the back of the garment. This provides a simple way to providecompression to the sigmoid and descending colon, and to the abdomengenerally, and may be desirable because the closing mechanism is on theback, where it will be less likely to be noticed.

FIG. 12 is another example for female patients. Aspects may include basematerials 50 that extend from the pubic line to just above the breasts.For example, this may form a tube top type shirt or undergarment 80.Notable in this example is that the closing mechanism 82 for theadjustable sigmoid and descending colon compression strap mechanism 84may comprise small, flexible plastic rings or clasps similar to those ona bra sewn into the base material 50 that the strap 84 can fasten ontoat varying degrees of tension similar to a bra strap. This exampleoffers sigmoid compression that is easily adjusted, yet is analternative to the loop strips sewn onto the base material in a similararea as depicted in FIGS. 9A-9C.

FIG. 13 illustrates an example in accordance with aspects of the presentinvention for females designed to be worn under formal clothing. Theundergarment 90 may provide support for the bust, and extend down acrossthe torso and pubic area all the way to the mid-thighs. The garment 90may be divided into three horizontal sections, the top and bottomsections being comprising base material 50 and the middle section 94comprising a knit fabric that may be selected to be slightly more firmand less elastic than the base material 50. Because this example 90 isdesigned to be worn under formal attire, it may be critical that itscompression mechanism not be bulky or visible under a flat dress.Accordingly, a simple sigmoid compression mechanism is incorporated intothis example, comprising 2 semi-elastic straps 94 sewn so that they layhorizontally in the middle section 92, and that when they lay flat,there is gap between the two straps 94 that falls overtop the sigmoidcolon. The straps 94 are then pulled together by a simple string cinch96 to generate compression. The excess string on the top of the cinch 96can then be tucked into a small pocket.

The example 100 depicted in FIGS. 14A and 14B includes an underwearundergarment for female patients that extends upward close thediaphragm, covering the torso. The garment 100 comprises a base material50 and features an abdominal strap 102 that sits atop the base material50 layer and circumvents the patient's lower abdomen. The strap 102originates from and is sewn along its left vertical edge 103 to the basematerial 50 midway between the patient's umbilicus and right hip. Thestrap 102 circumvents the lower abdomen in a counter-clockwise loop, andis held in place by several loops 108 sewn to the base material 50through which the strap 102 passes through. Once the strap 102 reemergeson the patient's right side, it may be pulled using the handle 104 andfastened securely using the closing mechanism 106 to the exterior sideof the first part of the strap 102. Once tightly secured, the strap 102will provide compression to the sigmoid and descending colon, as well asprovide general abdominal wall resistance. On the patient's back, thestrap passes through two loops in the base material 50 and overtop of asmall lumbar massage tool 110. The lumbar massage tool 110 may includeseveral semi-firm pressure nodes 112 that apply point-specific pressureto the lumbar muscles when the strap 102 is tightened. This may reducebloating by relaxing the muscles in the lumbar area in order to provokecontraction of the abdominal wall musculature through the process ofreciprocal inhibition.

FIGS. 15A and 15B depict alternative example aspects 120 for femalesincluding an undergarment comprised of base material 50 that is wornabout the hips and lower abdomen, extending from the mid-thigh up to aline a few inches past the umbilicus. A small pouch 122 may be situatedupon the base material 50 over the sigmoid colon on the patient's frontleft side. The pouch is attached on either side to a band 124 thatcontains two small wires 125 that fit into thin channels in the band 124that run along its length. Beginning on either side of the pouch 122 thebands 124 circumvent the patient's body and arrive at a closingmechanism 126 situated approximately behind the patient's right hip. Thewires 125 extend upwards from the channels in the band into the closingmechanism 126. The patient can adjust the level of compression appliedby the pouch 122 by turning the closing mechanism 126 clockwise orcounterclockwise. Situated in the pouch 122 is a removable insert 130that is compressed into the sigmoid and descending colon when pressureis applied. The insert 130 may be comprised of an inert, semi-rigid orflexible shape, or a pneumatic, inflatable bladder that provides focusedcompression to the sigmoid or descending colon; it may be an insert thatdelivers hot, cold, or TENS therapy; it may be a patch or device capableof transdermal drug delivery, it also may be a biosensor or series ofbiosensors that measure physiological activity. The insert also may beequipped with wireless transmitting capabilities including Blue Tooth inorder to transmit captured data to display devices (including computers,phones, tablets, etc.)

FIG. 16 illustrates example aspects for males patients comprised of asleeveless undergarment shirt 140 comprising base material 50 thatextends from the shoulders to the pubic line. A small band 142 is sewnovertop of the base material 50 in a ring that is passes over thesigmoid and descending colon and circumvents the patients lower abdomen.There are two wires 144 embedded in the band that attach to the rightand left side of an inelastic portion of the band 146 positioned overthe sigmoid colon, and attach to a tightening mechanism 148 situatedbehind the patient's right hip. The base material 50 under the inelasticportion of the band 146 such that the inelastic portion 146 touches thepatient's skin directly. Embedded in the inelastic portion 146 areseveral biosensors 149 that measure contractions in the lower bowel.These sensors 149 are powered by a small power source 150 embedded inthe band 146 behind the patient's right hip. Also embedded into theinelastic portion of the band 146 may be a wireless transmittingmechanism 152 capable of storing and sending captured data to software154 on a display device (such as a computer, mobile phone, or tablet).Another aspect may include a small band 156 not connected to theundergarment shirt 140 that the patient wears on their arm or leg.Embedded in the small band 156 may be several galvanic skin responsesensors that measure electrical conductance of the skin. Skinconductance varies greatly based upon sweat-induced moisture. Sweatingis controlled by the sympathetic nervous system, and thus skinconductance can be used as an indication of psychological (andphysiological) arousal, including anxiety. The small band 156 could alsobe equipped with a wireless transmitting mechanism capable of storingand transmitting captured data to the software 154 on a display device.In conjunction, the software 154 could be able to display and analyzepatterns and correlations between each data set to identifyrelationships between psychological arousal and dysmotility. Thesoftware 154 may also have a feature that would allow patients to inputthoughts, feelings, and records of meals, and store and later combinedthis information with the relevant physiological data captured at thatpoint in time.

FIGS. 17A and 17B depict an example 170 having alternate aspects formale patients including boxer-briefs composed of base material 50 thatextend from the upper thigh to a line slightly above the umbilicus. Onthe front side of the garment 170 in the area of the garment positionedover the patient's left lower abdomen, several transducers 172 are sewnon the inside of the base layer 50 such that the transducers 172 comeinto direct contact with the patient's skin. At the bottom of eachtransducer 172, there will be small ports that extend through the baselayer 50 and that connect each transducer 172 to the wires 174 thatconnect to the power source 176. The power source 176 is contained in asmall pouch 175 affixed to the external side of the base layer 50 on thepatient's back. Furthermore there is a strap 178 with a handle 180 thatapplies compression to the sigmoid and descending colon over top of thetransducers 172. Compression generated by the strap 178 may be adjustedusing the closing mechanism 182. Electro-stimulation may be controlledand adjusted by the patient using controls built into the power source176 or through another device (such as a mobile phone) that wirelesslycommunicates with the 176 power source using a wireless transmitting andreceiving module 184 embedded in the power source 176.

FIG. 18 presents an example system diagram of various hardwarecomponents and other features, for use in accordance with aspectspresented herein. For example, among other aspects those including anyof inserts within pouch 74, insert 130, wireless transmitting mechanism152, software 154, wireless transmitting and receiving module 184 may beimplemented using hardware, software, or a combination thereof and maybe implemented in one or more computer systems or other processingsystems. In one example, the aspects may include one or more computersystems capable of carrying out the functionality described herein. Anexample of such a computer system 1800 is shown in FIG. 18.

Computer system 1800 includes one or more processors, such as processor1804. The processor 1804 is connected to a communication infrastructure1806 (e.g., a communications bus, cross-over bar, or network). Varioussoftware aspects are described in terms of this example computer system.After reading this description, it will become apparent to a personskilled in the relevant art(s) how to implement the aspects presentedherein using other computer systems and/or architectures.

Computer system 1800 can include a display interface 1802 that forwardsgraphics, text, and other data from the communication infrastructure1806 (or from a frame buffer not shown) for display on a display unit1830. Computer system 1800 also includes a main memory 1808, preferablyrandom access memory (RAM), and may also include a secondary memory1810. The secondary memory 1810 may include, for example, a hard diskdrive 1812 and/or a removable storage drive 1814, representing a floppydisk drive, a magnetic tape drive, an optical disk drive, etc. Theremovable storage drive 1814 reads from and/or writes to a removablestorage unit 1818 in a well-known manner. Removable storage unit 1818,represents a floppy disk, magnetic tape, optical disk, etc., which isread by and written to removable storage drive 1814. As will beappreciated, the removable storage unit 1818 includes a computer usablestorage medium having stored therein computer software and/or data.

In alternative aspects, secondary memory 1810 may include other similardevices for allowing computer programs or other instructions to beloaded into computer system 1800. Such devices may include, for example,a removable storage unit 1822 and an interface 1820. Examples of suchmay include a program cartridge and cartridge interface (such as thatfound in video game devices), a removable memory chip (such as anerasable programmable read only memory (EPROM), or programmable readonly memory (PROM)) and associated socket, and other removable storageunits 1822 and interfaces 1820, which allow software and data to betransferred from the removable storage unit 1822 to computer system1800.

Computer system 1800 may also include a communications interface 1824.Communications interface 1824 allows software and data to be transferredbetween computer system 1800 and external devices. Examples ofcommunications interface 1824 may include a modem, a network interface(such as an Ethernet card), a communications port, a Personal ComputerMemory Card International Association (PCMCIA) slot and card, etc.Software and data transferred via communications interface 1824 are inthe form of signals 1828, which may be electronic, electromagnetic,optical or other signals capable of being received by communicationsinterface 1824. These signals 1828 are provided to communicationsinterface 1824 via a communications path (e.g., channel) 1826. This path1826 carries signals 1828 and may be implemented using wire or cable,fiber optics, a telephone line, a cellular link, a radio frequency (RF)link and/or other communications channels. In this document, the terms“computer program medium” and “computer usable medium” are used to refergenerally to media such as a removable storage drive 980, a hard diskinstalled in hard disk drive 970, and signals 1828. These computerprogram products provide software to the computer system 1800. Aspectspresented herein may include such computer program products.

Computer programs (also referred to as computer control logic) arestored in main memory 1808 and/or secondary memory 1810. Computerprograms may also be received via communications interface 1824. Suchcomputer programs, when executed, enable the computer system 1800 toperform the features presented herein, as discussed herein. Inparticular, the computer programs, when executed, enable the processor1810 to perform the features presented herein. Accordingly, suchcomputer programs represent controllers of the computer system 1800.

In aspects implemented using software, the software may be stored in acomputer program product and loaded into computer system 1800 usingremovable storage drive 1814, hard drive 1812, or communicationsinterface 1820. The control logic (software), when executed by theprocessor 1804, causes the processor 1804 to perform the functions asdescribed herein. In another example, aspects may be implementedprimarily in hardware using, for example, hardware components, such asapplication specific integrated circuits (ASICs). Implementation of thehardware state machine so as to perform the functions described hereinwill be apparent to persons skilled in the relevant art(s).

In yet another example, aspects presented herein may be implementedusing a combination of both hardware and software.

FIG. 19 is a block diagram of various example system components, inaccordance with aspects presented herein. FIG. 19 shows a communicationsystem 1900 usable in accordance with the present invention. Thecommunication system 1900 includes one or more accessors 1960, 1962(also referred to interchangeably herein as one or more “users”) and oneor more terminals 1942, 1966. In one aspect, data for use in accordanceaspects presented herein, for example, input and/or accessed byaccessors 1960, 1964 via terminals 1942, 1966, such as personalcomputers (PCs), minicomputers, mainframe computers, microcomputers,telephonic devices, or wireless devices, such as personal digitalassistants (“PDAs”) or a hand-held wireless devices coupled to a server1943, such as a PC, minicomputer, mainframe computer, microcomputer, orother device having a processor and a repository for data and/orconnection to a repository for data, via, for example, a network 1944,such as the Internet or an intranet, and couplings 1945, 1946, 1964. Thecouplings 1945, 1946, 1964 include, for example, wired, wireless, orfiberoptic links. In another aspect, the method and system presentedherein operate in a stand-alone environment, such as on a singleterminal.

As depicted in FIG. 21, other aspects of the present invention mayinclude an elastic or semi-elastic band 40 or garment base material 50that is fastened around the abdomen and has one or more secondary bands,with each secondary band attached to the primary band 40 or basematerial 50 along one vertical edge 2104 that is coincident with theleft midclavicular line 2106, as depicted in FIG. 20A, when the band isfastened around the abdomen or the garment is worn.

FIG. 22 depicts a similar secondary band configuration, except that thesecondary bands are not attached to the band 40 or garment 50 along thesame vertical line, coincident with the left midclavicular line, but areinstead attached along vertical lines equidistance 2204 from leftmidclavicular line. In this aspect, the secondary band attached to theright of the left midclavicular line (from the perspective of thewearer) 2206 is configured to stretch horizontally (longitudinally) fromleft to right, and the secondary band attached to the left of the leftmidclavicular line 2208 is configured to stretch from horizontally(longitudinally) from right to left. It is important to note thataspects of this invention allow various combinations of base materials,garment styles (such as abdominal bands and shape-fittingundergarments), closing mechanisms, and compression mechanisms to suitthe preference of the user. For example, in FIG. 22 the secondary bandconfiguration is incorporated into a female underwear undergarment thatextends up across the torso to just below the bust line, a style similarto the aspect depicted in FIG. 10.

In aspects of the invention incorporating one or more adjustablesecondary straps that generate compression when stretched and fastened,it may be advisable that the straps are designed in such a way so thatthe full, intended treatment range of compression can be achievedthrough adjustment by a user who is wearing the device at the time.Practically, if compression level is adjusted by stretching or relaxingthe tension in one or more secondary bands and then (re)-fastening thesecondary band(s) to the band or base material, then the apparatus andsecondary bands must be capable of generating intended compressionlevels taking into account that the areas of the band or base materialto which the secondary straps may be attached will be limited to theareas that the user can easily reach while wearing the device. FIGS. 23Aand 23B depict areas of the band 40 to which the user's reach will limitwhere the secondary straps may be fastened. With respect to thesecondary strap 2308 that stretches from left to right, thecircumferential region of possible attachment 2304 is boundapproximately by the anterior midline and the left posterior axillaryline. Reciprocally, the secondary strap 2310 that stretches from rightto left is bound by the left anterior axillary line and the posteriormidline. In this aspect, the elasticity of the secondary bands must beof a level that allows for the intended treatment levels of compressionto be achieved when the secondary bands are stretched and fastened tothe band 40 within the respective zones (2304, 2306). Of note, novertical bounds to the zones of possible secondary strap fastening aredescribed. Although vertical bounds are apparent in FIG. 22, it is thestyle and application area of the band 40 or garment 50 that mayvertically limit the area to which a user can fasten the secondary straprather than the anatomical features of the wearer.

In alternative aspects of the invention, the band or garment basematerial may include a pad or an inflatable air bladder specificallydesigned to apply compression to the left lower abdomen and sigmoidcolon. FIG. 24 depicts a band 40 with a closing mechanism 42 used toconnect one end of the band to the other end of the band around a user'slower abdomen with an embedded air bladder 2402, air pump 2404, andpressure gauge 2406. In this aspect, the air bladder 2402 is positionedover the left lower abdomen when the band 40 is applied. The shape ofthe air bladder 2402 in this aspect is oblong, with a lengthapproximately twice its width. The air bladder 2402 is oriented longwiseat a 30-60 degree angle (from horizontal), with its right side lowerthan its left side. In FIG. 24 the angle depicted is 45 degrees. The airbladder 2402 may be positioned, attached, or embedded in the band 40 ina way that when the band is properly fastened, the air bladder 2402 ispositioned within the left lower abdomen and approximately between theleft sternal line 2408 and the left anterior axillary line 2410 (bothlines are also depicted in FIG. 20A and 20B)—although in other aspects,the position of the bladder may extend horizontally to or just past themidline 2412. Compression may be applied and adjusted by inflating anddeflating the air bladder 2402 using the embedded air pump 2404.

FIG. 25 depicts a base material 50 with an embedded air bladder 2402,air pump 2404, and pressure gauge 2406, as well as two secondary straps2502/2504, each with a closing mechanism 2506 allowing the straps2502/2504 to be fastened to the exterior of the base material 50. Inthis aspect, the secondary straps 2502/2504 may be attached or sewn tothe base material along their left (2502) and right (2504) edges in away so that the line upon which each strap is sewn or attached to thebase material is coincident with approximately one side of the contourof the air bladder. These lines of attachment are indicated in FIGS. 25as 2508 and 2510. The contoured attachment line may provide improved fitand comfort, and may maximize the efficiency of the force exerted by thesecondary straps used to compress the air bladder into the left lowerabdomen.

FIG. 26 reflects an alternative aspect of the invention, and depicts aband with an embedded or inserted pad 2602, similarly shaped andpositioned to the air bladder described in FIG. 24, with a secondarystrap 2604 that stretches horizontally across the location of the pad sothat when it is fastened to the exterior of the band, it compresses thepad 2602 into the left lower abdomen.

Thus, aspects may include an apparatus, system, or method for treatingsymptoms of

IBS that provide patients with treatment that can be initiated and havea treatment level adjusted in real-time, in acute response to symptoms.This provides a patient with real time symptom management. For example,an apparatus may comprise an elastic portion capable of applyingcompression across the abdomen of a user and a component capable ofapplying adjustable compression to a target area in order to adjusttreatment of IBS symptoms.

Aspects may further include a method or apparatus for treatment ofdysmotility associated with IBS and/or other functional GI disorders.The method may include applying external compression to at least asigmoid colon and/or lower left abdomen of a patient. Aspects mayfurther include applying compression to a descending colon, e.g., in aleft middle portion of the patient's abdomen in order to promote bowelrelaxation and/or reduction of bowel spasms. Compression may be applied,maintained, and/or adjusted, e.g. using an apparatus as describedherein.

Aspects may further include a method or apparatus for treating abdominalpain associated with IBS or other functional GI disorders. The methodmay include applying external compression to at least a sigmoidcolon/left lower abdomen of a patient in a manner configured toblock/dampen visceral pain signal transmission to the brain of thepatient. The method may include applying compression to the descendingcolon (left middle abdomen) and the lower abdomen generally in order toblock/dampen visceral pain signal transmission to the brain. Compressionmay be applied, maintained, and/or adjusted, e.g. using an apparatus asdescribed herein.

Aspects may further include a method or apparatus for treatingdistention and bloating associated with IBS or other functional GIdisorders. The method may comprise applying external compression to atleast the sigmoid colon/left lower abdomen of a patient in a mannerconfigured to prevent excessive expansion of the colon lumen due theaccumulation of intestinal gas in that region of the colon. The methodmay further include applying compression to the descending colon (leftmiddle abdomen) of the patient, in order to prevent excessive expansionof the colon lumen due the accumulation of intestinal gas in that regionof the colon. Compression may be applied, maintained, and/or adjusted,e.g. using an apparatus as described herein.

Aspects may further include a method or apparatus for treatingdistention and bloating associated with IBS or other functional GIdisorders. The method may include applying external compression acrossthe abdominal wall of a patient as a means to oppose and resistrelaxation of the abdominal wall that occurs in response to intestinalgas and pressure. Compression may be applied, maintained, and/oradjusted, e.g. using an apparatus as described herein.

Aspects may further include a method or apparatus for treatingdistention and bloating associated with IBS or other functional GIdisorders. The method may comprise promoting relaxation of the musclesof the lower back and lumbar region through the use of wearable massagemechanisms in order to provoke reciprocal contraction of the abdominalwall in order to oppose and resist relaxation of the abdominal wall thatoccurs in response to intestinal gas and pressure. The apparatus maycomprise an apparatus include aspects presented herein and may furtherinclude a massage mechanism configured to provide a massaging action toa lower back or lumbar region of a patient wearing the apparatus.

Aspects may further comprise a method or apparatus for treatingdistention and bloating associated with IBS or other functional GIdisorders. The apparatus may comprise a wearable configured to detectabdominal wall contraction. The wearable may be configured to alert auser when unconscious abdominal wall relaxation is occurring so that theuser may consciously contract their abdominal wall and oppose therelaxation and distention. The wearable may be configured to allowadjustment a compression applied to a lower abdomen of the user. Forexample, upon receiving the alert, the user may determine whether toadjust the compression. In another example, the wearable mayautomatically adjust a level of compression based on detecting abdominalwall relaxation. For example, when abdominal wall contraction ismeasured above a set level, the wearable may automatically adjust thecompression. Compression may be applied, e.g., using aspects presentedherein.

Example aspects of the present invention have now been described inaccordance with the above advantages. It will be appreciated that theseexamples are merely illustrative of aspects of the present invention.Many variations and modifications will be apparent to those skilled inthe art.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Further, somesteps may be combined or omitted. The accompanying method claim presentselements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

The previous description is provided to enable any person skilled in theart to practice the various aspects described herein. Variousmodifications to these aspects will be readily apparent to those skilledin the art, and the generic principles defined herein may be applied toother aspects. Thus, the claims are not intended to be limited to theaspects shown herein, but is to be accorded the full scope consistentwith the language claims, wherein reference to an element in thesingular is not intended to mean “one and only one” unless specificallyso stated, but rather “one or more.” Unless specifically statedotherwise, the term “some” refers to one or more. Combinations such as“at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B,C, or any combination thereof” include any combination of A, B, and/orC, and may include multiples of A, multiples of B, or multiples of C.Specifically, combinations such as “at least one of A, B, or C,” “atleast one of A, B, and C,” and “A, B, C, or any combination thereof” maybe A only, B only, C only, A and B, A and C, B and C, or A and B and C,where any such combinations may contain one or more member or members ofA, B, or C. All structural and functional equivalents to the elements ofthe various aspects described throughout this disclosure that are knownor later come to be known to those of ordinary skill in the art areexpressly incorporated herein by reference and are intended to beencompassed by the claims. Moreover, nothing disclosed herein isintended to be dedicated to the public regardless of whether suchdisclosure is explicitly recited in the claims. No claim element is tobe construed as a means plus function unless the element is expresslyrecited using the phrase “means for.”

What is claimed is:
 1. Apparatus for treating symptoms of IrritableBowel Syndrome (IBS), comprising: a base material comprising a materialthat fits to the body of a user; an elastic portion capable of applyingcompression across the abdomen of a user; and a tension adjustingmechanism for adjusting the compression applied to the abdomen in orderto treat the symptoms of IBS.
 2. The apparatus of claim 1, wherein thetension adjusting mechanism is capable of adjusting the compression toapply a lower abdominal pressure and additional, targeted pressure to asigmoid and descending colon of the user.
 3. The apparatus of claim 2,wherein the apparatus comprises an undergarment.
 4. The apparatus ofclaim 2, wherein the tension adjusting mechanism comprises multipleconnector strips attached to the base material and correspondingreceiving strips that enable the connector strips to be fastened in anadjustable manner to adjust the compression applied to the abdomen. 5.The apparatus of claim 2, wherein the tension adjusting mechanismcomprises an elastic strap attached to the base material at an anglesuch that the elastic strap wraps from a first position around the backof the user to a second position located higher than the first position.6. The apparatus of claim 1, further comprising: a pouch configured tobe positioned over the abdomen of the user, wherein the tensionadjustment mechanism adjusts the compression of the pouch against theuser.
 7. The apparatus of claim 6, wherein the pouch is configured to bepositioned over a sigmoid colon of the user.
 8. The apparatus of claim6, further comprising: multiple straps extending from the pouch, whereinthe tension adjusting mechanism connects to the multiple straps toadjust the compression of the pouch to the abdomen of the user.
 9. Theapparatus of claim 8, wherein the tension adjusting mechanism comprisesa crank attached to the base material at a side opposite the pouch. 10.The apparatus of claim 6, wherein the pouch is configured to receive atleast one selected from a group consisting of a shaped removable insert,an inflatable bladder, a heat pack, a cold pack, an electro-stimulator,a biosensor that measures physiological activity, and a wirelesstransmitter.
 11. The apparatus of claim 1, wherein the tension adjustingmechanism comprises multiple plastic rings or metal clasps that enable ahook to fasten at multiple locations in order to adjust the compression.12. The apparatus of claim 1, wherein the apparatus comprises threehorizontal sections, an upper and lower section comprising the basematerial, and a middle section comprising a material that is lesselastic than the base material.
 13. The apparatus of claim 12, whereinthe tension adjusting mechanism comprises a cinch.
 14. The apparatus ofclaim 1, further comprising: a lumbar massage component configured toapply point-specific pressure to the lumbar muscles of a user, whereinthe tension adjusting mechanism adjusts the compression of the lumbarmassage component against the user.
 15. The apparatus of claim 1,further comprising: biosensors configured to measure contractions in thebowel.
 16. The apparatus of claim 15, further comprising: a wirelesstransmitter capable of storing and transmitting captured data from thebiosensors.
 17. The apparatus of claim 16, further comprising: agalvanic skin response sensor configured to measure electricalconductance of the skin.
 18. The apparatus of claim 1, furthercomprising: multiple transducers positioned to be in direct contact withskin of the user's abdomen; and a power source for driving thetransducers to apply electro-stimulation to the user's abdomen.
 19. Asystem comprising: a processor configured to: receive a first set ofdata from biosensors configured to measure contractions in the bowel;receive a second set of data from a galvanic skin response sensorconfigured to measure electrical conductance of the skin; and analyzepatterns between the first and second sets of data.
 20. The system ofclaim 18, further comprising: receiving user input regarding at leastone selected from a group consisting of thoughts, feelings, and recordsof meals; and correlating the user input to the analyzed sets of data.